BioSistemika

BioSistemika develops custom laboratory software for instrument manufacturers, laboratories, and software providers in the life sciences, pharma, and in vitro diagnostics (IVD) sectors. The company has operated for more than 13 years and employs close to 50 people, having delivered over 100 software, digitalization, and R&D projects.

Its interdisciplinary teams combine scientists, laboratory experts, UX designers, and software engineers, covering work from requirements gathering and risk assessment through coding, implementation, and validation.

Services

• Software development and engineering for life sciences, pharma, IVD, and adjacent industries, including user-facing applications and scalable backend systems.
• IVD medical software development aligned with IVDR standards and regulations, with documentation for audit readiness.
• Laboratory digitalization services covering data organisation, process automation, and data integrity, tailored to individual lab needs.
• Compliance and integrations, including device connectivity and readiness for 21 CFR Part 11.
• Workshops and expert training on compliance standards and regulatory transitions such as IVDR, delivered by in-house specialists and industry partners.
• Laboratory digitalization consulting, including guidance on LIMS, ELN, and change management strategy.

Project types and scientific domains

• Cloud applications for laboratories, data management, analysis, and visualisation; mobile and desktop software for laboratory instruments; APIs, plugins, and middleware integrations; algorithm development and machine learning.
• Domains include molecular biology, in vitro diagnostics, drug discovery and biologics, image analysis, spectrometry, food analysis, nanomaterials, liquid handling, and lab automation.
• Past project examples include data management software for on-site testing devices, IVD and RUO analytical software for a European project, and digitalization strategy and LIMS implementation for a biotech company.

Technology stack

• Desktop: Windows desktop applications built with various technologies.
• Mobile: native Android development in Java or Kotlin, plus cross-platform apps using Ionic, Cordova, and Angular.
• Web: a range of web technologies for web application development.
• Hardware interfacing: integration with instruments via serial, Bluetooth, USB, and vendor SDKs or APIs.

Project teams

• Standard project staffing includes application specialists, senior and mid-level software developers, a quality assurance specialist, a key account manager, and a UX designer.

Quality and regulatory framework

• Quality management: ISO 13485 and ISO 9001:2015.
• Regulations implemented: IEC 62304, GxP requirements, and FDA 21 CFR Part 11.
• Medical device coverage: EU IVD, US FDA, and UK MDR 2002.

Internal R&D

• DATANA DNA Data Storage is an internal BioSistemika project developing patented technology for DNA-based data storage, focused on data density, stability, and sustainability.

BioSistemika positions itself as a long-term partner for laboratory digitalization, combining domain knowledge in laboratory workflows with software engineering and regulatory expertise.